CLASS II Drug recall · Reported 9 Mar 2022 · FDA Enforcement Report
Dexamethasone Elixir, USP 0.5 mg/, Net recalled
Morton Grove Pharmaceuticals is recalling Dexamethasone Elixir, USP 0.5 mg/, Net, distributed nationwide in the US. The recall was initiated on 21 Feb 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0713-2022
- FDA event ID
- 89624
- Recalling firm
- Morton Grove Pharmaceuticals, Morton Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Feb 2022
- FDA classified
- 21 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Feb 2022 | Recall initiated by company | |
| 9 Mar 2022 | Published in enforcement report | +16 days |
| 21 Mar 2022 | Classified by FDA | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Which lots are affected?
Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Morton Grove Pharmaceuticals
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Promethazine With Codeine Oral Solution recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
Other Dexamethasone recalls
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Sodium Phosphate Injection, USP, 100 mg recalledDexamethasone Sodium Phosphate | Somerset Therapeutics | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone Sodium Phosphate injection USP, 120mg recalled by Eugia USDexamethasone Sodium Phosphate | Eugia US | Potency & Assay | Nationwide |
| Drug | CLASS II | Dexamethasone 16mg/ML Vial) Injectable recalled by Pharmacy Innovations | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone sodium phosphate, sterile otic solution recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Dexamethasone (LA) Injectable Suspension recalled | Fusion IV Pharmaceuticals | Sterility | Nationwide |